Health economic evaluation of Oncotype DX in breast cancer

TLV has performed a health economic evaluation of Oncotype DX on the request of the Swedish regions. Oncotype DX is a molecular test to assess the risk of developing distant metastases in breast cancer. The test also gives information on the expected benefit of chemotherapy.

On the request of the Medical Technology Council (MTP-rådet), representing the Swedish regions, TLV has performed a health economic evaluation of Oncotype DX. The evaluation is part of the decision basis in the upcoming national recommendation that the Medical Technology Council will issue concerning Oncotype DX.

Oncotype DX is a gene expression analysis of breast cancer tumor tissue that assesses the risk of developing distant metastases (prognostic performance). The test also estimates the expected benefit of chemotherapy (predictive performance). The test result is used in addition to conventional clinical-pathological assessment to decide whether the patient should be treated with chemotherapy or not.

In the Swedish guidelines for breast cancer, gene expression analysis is recommended for a specific subgroup of patients where it is difficult to estimate the risk of the development of distant metastases and whether the patient should be treated with chemotherapy or not. Oncotype DX is one of the tests that is mentioned in the Swedish guidelines. The patient group that is included in TLV’s main scenario is chosen to reflect the recommendations in the guidelines as close as possible.

The uncertainties in the results of TLV’s analysis is moderate and lies foremost in the assumptions related to the predictive performance of Oncotype DX. However, these uncertainties are not so large that they are expected to affect the conclusion concerning the product’s cost-effectiveness.

TLV estimates that the use of Oncotype DX in addition to clinical-pathological assessment leads to the addition of 0.24 quality adjusted life years (QALY) on average, and that the treatment cost is around 50 500 Swedish kronor less compared to only clinical-pathological assessment. The health economic analysis thus indicates that the use of Oncotype DX gives greater benefit compared to the alternative, and at a lower cost.